InterStim™ SureScan™

GUDID 00763000203764

LEAD 978B133 ISTM SSMRI 4.32MM EMAN US

MEDTRONIC, INC.

Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode
Primary Device ID00763000203764
NIH Device Record Keycea6088a-df56-4efc-860a-ccb0040f11f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterStim™ SureScan™
Version Model Number978B133
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000203764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZWStimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-18
Device Publish Date2020-08-10

On-Brand Devices [InterStim™ SureScan™]

00763000203801LEAD 978B141 ISTM SSMRI 4.32MM EMAN US
00763000203764LEAD 978B133 ISTM SSMRI 4.32MM EMAN US
00763000203726LEAD 978B128 ISTM SSMRI 4.32MM EMAN US
00763000203689LEAD 978A141 ISTM SSMRI 2.16MM EMAN US
00763000203641LEAD 978A133 ISTM SSMRI 2.16MM EMAN US
00763000203603LEAD 978A128 ISTM SSMRI 2.16MM EMAN US

Trademark Results [InterStim]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTERSTIM
INTERSTIM
74469362 2072076 Live/Registered
Medtronic, Inc.
1993-12-13

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